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Lower risk Medical device recall · FDA · Published March 19, 2026

DONJOY ICEMAN Cold Therapy Unit Recall: Broken Connector May Cause Therapy Interruption

DONJOY recalls ICEMAN cold therapy units with model 11-1424 due to a broken connector that may interrupt prescribed cold therapy. Affected units were sold starting May 2023. Consumers should contact DONJOY for a repair or replacement.

🇺🇸 FDA recall #Z-2136-2026Medical deviceDONJOY ›
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Contact the company

Recalling firmDJO, LLC5919 Sea Otter Pl Ste 200 · Carlsbad, CA 92010-6750
✎ GovInfoNow plain-language explainer

What happened, in plain English

DONJOY is recalling its ICEMAN cold therapy units (model 11-1424) because a broken connector can cause temporary interruptions in cold therapy. This may affect rehabilitation progress if the therapy is interrupted during recovery. Read more at govinfonow.com/recall/49658-donjoy-iceman-cold-therapy-unit-recall-broken-connector-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/49658-donjoy-iceman-cold-therapy-unit-recall-broken-connector-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2136-2026

Cite this page

“DONJOY ICEMAN Cold Therapy Unit Recall: Broken Connector May Cause Therapy Interruption.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49658-donjoy-iceman-cold-therapy-unit-recall-broken-connector-may-cause. Based on FDA recall #Z-2136-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2026%22&limit=1).

Why it’s dangerous

The unit has a connector that can become broken, leading to a temporary loss of cold therapy function. This interruption could delay healing or cause pain if the therapy is needed during recovery.

Who’s affected

People using the DONJOY ICEMAN cold therapy unit for rehabilitation or pain management are affected. Those with medical conditions requiring consistent cold therapy are at higher risk.

How to tell if you have this one

Check for the model number 11-1424 on the unit. The product was sold starting May 2023. The IceMan CLASSIC3 is a cold therapy device for rehabilitation.

  • Brand
    DONJOY
  • Product
    Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-2134-2026Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no; Model/Catalog Number: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100596
Z-2135-2026Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No; Model/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 008889120058691412
Z-2136-2026Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No; Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305480
Z-2137-2026Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No; Model/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 0088891200037696
Based on the official FDA remedy

What to do — step by step

  1. Contact DONJOY

    Reach out to DONJOY directly for repair or replacement options for the affected model.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 32 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Mar 19, 202612. FDA classified it Class II: May 8, 202623. Published in FDA’s Enforcement Report: May 20, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2136-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2136-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA